NCT00685191

Brief Summary

The study purpose is to investigate plasma HIV-1 RNA dynamics in subjects initiating raltegravir-based salvage therapy and quantify the corresponding changes in levels of cellular HIV-1 DNA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

10 months

First QC Date

May 23, 2008

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

RaltegravirHIVdynamicsviral loadTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Change in viral load from day 0 to 7

    1 week

Secondary Outcomes (1)

  • Intracellular levels of HIV-1 proviral DNA and LTR circles

    24 weeks

Study Arms (1)

1

EXPERIMENTAL

HIV-1-infected subjects initiating raltegravir-including salvage therapy

Drug: Salvage antiretroviral therapy including raltegravir

Interventions

Salvage antiretroviral therapy including raltegravirDRUG

Initiation of raltegravir-including salvage antiretroviral therapy

Also known as: RAL
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.
  • Subjects initiating raltegravir plus another fully active antiretroviral drug.

You may not qualify if:

  • Pregnancy, or fertile women willing to be pregnant.
  • Active substance abuse or major psychiatric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital U. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bonaventura Clotet, MD,PhD

    Hospital U. Germans Trias i Pujol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(1)